NCHR Testifies at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting on Shield Guardant Health

May 23, 2024: NCHR provided public testimony at the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting regarding the safety and effectiveness of Shield Guardant blood test for colorectal cancer screening. We advised more research was needed prior to approving the test due to the low sensitivity in detecting colorectal cancer at the earliest stages.

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NCHR Testifies at the Pediatric Oncology Subcommittee Meeting

May 22, 2024: NCHR provided public testimony at the pediatric oncology subcommittee meeting regarding Section 504 of the 2017 FDA Reauthorization Act. We expressed concern that efforts to increase availability of new treatments for pediatric cancer have resulted in more planned studies but not in more treatments. We recommended sponsors prioritize engaging with key stakeholders such as the EMA Paediatric Committee, FDA Pediatric Review Committee, FDA Oncology Subcommittee of the Pediatric Review Committee, the Oncology Center of Excellence, and the use of independent Pediatric Expert Groups.

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